GEN-MKT-18-7897-A
Feb 29, 2016 | Biopharma, Blogs | 0 comments
Traditionally, the pharmacokinetic profile of biotherapeutics such as insulin glargine, adalimumab, trastuzumab and others, used gold standard LBAs to assess dose-response during drug discovery and development. However, LBAs require a specific antibody reagent to be developed for each mAb variant, a process that is often incompatible with the compressed timeframes encountered during the initial stages of drug development. More recently, LC-MS/MS-based methods have come to the forefront as a feasible approach for the quantification of biotherapeutics in biological matrices, with many of these methods relying on proteolytic digestion of the target mAb and quantification of multiple unique signature peptides, which are equivalent to levels of the whole protein. But, to drive the real biological need, we have to quantify the pharmacologically active or free form of the drug to assess safety, efficacy and proper dosing regimen. Here we present a solution to get the best of both technologies: an LBA strategy to capture the active form of the drug; and an LC-MS assay to selectively quantify the free and circulating drug.
In monoclonal antibody (mAb) development, assessment of purity and integrity of the protein in question is critical. CE‑SDS is the gold standard assay and is routinely run from analytical development through QC and lot release. It’s trusted because it consistently delivers quantitative, size‑based insight into purity and fragmentation, and it fits naturally into regulated environments.
In drug discovery and development, Metabolite Identification (Met ID) plays a critical role in understanding biotransformation pathways, ensuring safety, and meeting regulatory requirements. Advanced mass spectrometry techniques have revolutionized this process, particularly through electron-based fragmentation methods such as Electron Activated Dissociation (EAD) and Electron Transfer Dissociation (ETD). While both techniques leverage electron interactions to generate informative fragment ions, they differ significantly in mechanism, performance, and suitability for Met ID workflows.
In analytical laboratories, performance is not optional. Whether supporting regulated pharmaceutical workflows, high-throughput CRO operations, clinical reporting, or food and environmental testing, your mass spectrometry and capillary electrophoresis systems are critical to productivity, compliance, and scientific confidence.
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